Seretide 250mcg/125mcg Evohaler switch to Fostair 100/6 MDI in COPD.

Seretide 250mcg/125mcg Evohaler switch to Fostair 100/6 MDI in COPD. Applies to HaRD CCG employed Pharmacists and Medicines Optimisation Technicians These protocols are produced by the NY&AWC MM team hosted by HaRD CCG for use by their employed MM team members. They can be adopted for use by other healthcare staff working in GP practices across NY&AWC CCGs but HaRD CCG accepts no responsibility for the use and application of these protocols in these situations. External staff working to these protocols must agree with their own employer whether they are competent and able to work to these protocols. Rationale The NICE Clinical Guideline 101 and NICE pathway inhaled therapy in COPD (NICE, 2013) provides guidance on the use of ICS/LABA combination inhalers dependent on FEV1 (Global Initiative for COPD, 2014) to improve symptoms, lung function, quality of life and reduce the frequency of exacerbations. It is indicated that if a combination ICS/LABA inhaler device is appropriate, the choice of drug(s) should take into account the person's symptomatic response and preference, and the drug's potential to reduce exacerbations, adverse effects and cost. Seretide Evohaler is not licensed for use in COPD. Fostair MDI is licensed for COPD patients with FEV1 <50% predicted and represents a cost effective choice (PrescQUIPP, 2013), equivalent to other combination choices such as Seretide. Where CCG COPD guidelines have been developed and implemented, this switch should reflect the formulary choices adopted within those documents. Method 1. Staff working to the protocol should be familiar with the current BNF advice and the Summary of Product Characteristics for medicines included in the protocol. 2. Check the practice has agreed to the protocol and a signed copy is in place. 3. Check for any extra exclusions or amendments to the protocol made by the practice with particular consideration to the criteria the practice would like to be applied to determine which patients are flagged to the GP (or alternative prescriber) for review and consideration of treatment. 4. Rearrange practice formulary/add do not use codes to prevent future inadvertent prescribing. 5. Notify local pharmacies/dispensary of work being undertaken and inform any relevant practice staff e.g. dispensary staff. 6. Run a computer search to identify patients who are currently receiving prescriptions for Seretide 125 microgram and 250 microgram Evohaler (generically or by brand) for this indication. 7. Use the data collection form (Appendix 1) and the medical records to record the following: Patient identity Age Inhaler strength, dose & quantity Indication Any allergies? Protocol title: Seretide to Fostair in COPD Page 1 of 12 NYAWC MMT

Compliance: number of combination Evohalers in last 12 months Compliance: number of other inhalers in last 12 months e.g. LAMA,SAMA, SABA Previously tried Fostair? Y/N. If yes why stopped. Is the patient using a spacer device? This inhaler requires an Aerochamber and is not to be used with a Volumatic. Any patients prescribed a Volumatic should be flagged to a prescriber for this to be added to the patient s prescription (see Special Considerations point 9). Date of last COPD review Number of exacerbations in last 12 months FEV 1 (less or more than 50%) Documented evidence that unable to use an MDI Flag to GP/ respiratory specialist? Y/N Is the patient suitable to switch? Y/N Switched & letter sent to patient Note: definition of an exacerbation is an acute event characterised by a worsening of the patient s respiratory symptoms that is beyond normal day to day variations and leads to a change in medication. Change medication could be starting a course of steroids and/or antibiotics or a significant increase in use of a SABA +/- SAMA. 8. Identify patients to exclude, those considered suitable to switch to Fostair 100/6 MDI, and those needing special consideration by GP (see section on exclusions and special considerations). 9. If the patient is excluded, add a consultation note to the patient record, listing reasons why they are unsuitable. 10. For those patients who can be switched now or when approved by GP/ other prescriber; change repeat medication on computer (see Table 1 below for guidance on switching). 11. Ensure that the old medication is archived. 12. Send a letter to the patient advising them of the change (note: see points to discuss with practice regarding how the switch will be managed). Liaise with practice staff to organise mail merge of letters and posting. At the end of the session, for all those changes that have been completed, a letter must be ready to send to the patient for information. 13. Add READ code 8BIr or XaJKo (on Systm One) drug changed to cost effective alternative for all patients switched. 14. Problem link drug to disease (where possible). 15. Inform relevant practice staff. 16. Record the numbers/patients changed using an activity log. 17. Use the activity log to review all changes made and to measure the effectiveness of the switch. Estimate cost savings made and present results back to the practice and organisation 18. Continue to monitor the long term outcomes of the switch e.g. cost savings, complaints, problems encountered etc. Protocol title: Seretide to Fostair in COPD Page 2 of 12 NYAWC MMT

Table 1. Switch recommendation from Seretide Evohaler to Fostair 100/6 MDI Seretide to Fostair (beclometasone and formoterol)100/6 MDI Current prescription Seretide 125 Evohaler Seretide 250 Evohaler 1 puff TWICE daily Seretide 250 Evohaler Switching this strength can be undertaken IF agreed by a prescriber on an individual patient basis Product and dose to switch to Fostair 100/6 Inhaler Fostair 100/6 Inhaler Fostair 100/6 Inhaler The summary of product characteristics (SPC) advises that the particles of beclometasone (BDP) in Fostair are extra fine and more potent than in standard formulations of BDP: 100 micrograms of extra fine BDP in Fostair are equivalent to 250 micrograms of standard BDP. Exclusions 1. Exclude patients diagnosed with asthma alone. Any form of respiratory disease (other than COPD) is excluded from this protocol. A protocol from Seretide to Flutiform or Fostair in asthma is available for use if appropriate/agreed. 2. Exclude patients with a history of intolerance/ hypersensitivity to ingredients of Fostair MDI inhaler. Fostair contains small amounts of ethanol: be aware should this need to be avoided for religious reasons. However at normal doses the amount of ethanol is negligible. 3. Exclude patients who find it easier to use a breath actuated inhaler rather than a metered dose inhaler (MDI) and would not be suitable for a spacer device. 4. Exclude children and adolescents less than 18 years. To flag up for special consideration by GP/ Respiratory specialist (EMC, 2014) 1. Flag with a prescriber any patient who has any significant drug interactions with Fostair (see BNF Appendix 1 and data sheet (available at www.medicines.org.uk for further details). Also check GP prescribing systems for any interactions at the time of adding. Seek advice from MM team pharmacist as to the significance of the interaction, and flag to the GP for consideration. Proceed to switch only if individual patient approval is given from a practice prescriber. Document and retain that approval. 2. Flag any patients who have a Read code for both COPD and asthma. Diagnosis of COPD to be confirmed and GP to clarify the treatment plan as to whether asthma is stepped down and treatment initiated for COPD in line with NICE. Seek advice from a MM team pharmacist if required. Proceed to switch only if individual patient approval is given from a practice prescriber. Document and retain that approval. 3. Flag any patients under 35 years of age (but 18 years or over) for prescriber approval. Proceed to switch only if individual patient approval is given from a practice prescriber. Document and retain that approval. 4. Flag any patients with diagnosis of COPD and FEV1 >50% and less than 2 exacerbations in the last 12 months these may be appropriate for step down (please see PrescQIPP guidance.) Fostair is not licensed however it may be considered appropriate for the patient e.g. if a licensed device, DPI, is not Protocol title: Seretide to Fostair in COPD Page 3 of 12 NYAWC MMT

suitable for this patient. Proceed to switch only if individual patient approval is given from a practice prescriber. Document and retain that approval. 5. Flag any patients with COPD and no FEV1 recorded. These may need calling in for spirometry or review. Proceed to switch only if individual patient documented approval is given from a practice prescriber. Document and retain that approval. 6. Flag any patients where COPD exacerbations have not been reduced- check compliance and order history of inhalers. Proceed to switch only if individual patient approval is given from a practice prescriber. Document and retain that approval. 7. Flag any patients on disulfiram or metronidazole as manufacturer s Summary of Product Characteristics does not rule out a theoretical interaction with alcohol. Proceed to switch only if individual patient approval is given from a practice prescriber. Document and retain that approval. 8. Flag patients with poor inhaler technique / history of poor compliance (from number of inhalers used in previous 12 months) these patients should be flagged to the prescriber for consideration of switch and how to improve technique or compliance (support for this could be offered by a community pharmacy via the new medicine service (NMS) review or medicines use review (MUR) or via a practice nurse). 9. Flag patients prescribed a Volumatic device as Fostair is not licensed with this device. The Aerochamber plus device is the appropriate spacer device. A request to prescribe an Aerochamber must be made to a prescriber at the time of making the switch via the Task function. This should be followed up by the MM team member to ensure that it has happened. These patients new to the Aerochamber will require counselling this can be done by the community pharmacist or the practice nurse- it is the responsibility of the PST member to oversee this e.g. document what action has been taken and by whom. Please see Appendix 2 for a letter that can be shared with community pharmacists if they agree to perform a new medicines service for any patients. 10. Flag any patients currently prescribed Seretide 250mcg Evohaler 2 puffs bd: this is a high dose and the change to Fostair, as detailed in Table 1, is considered a step down of steroid dose and patients may need to be followed up after changing to the new inhaler. Proceed to switch only if individual patient approval is given by a practice prescriber. Document and retain that approval. 11. Any patient that you are concerned may be unsuitable for switching e.g. acutely worsening COPD, or other prescribing issue that you are concerned about flag to GP or practice nurse and seek approval to switch on an individual patient basis. Document and retain approval if given. Points to discuss with practice 1. Who is the contact in the practice for the project? 2. Seek agreement from practice as to whether palliative care patients can be switched. Patients considered to be in the last few weeks of life would not normally be recommended for the switch. 3. Discuss with the practice how they would like the review to be managed e.g. how patients are going to be reviewed by the practice following this data collection by Practice Nurse/GP? 4. Consider how patients will be followed up to assess their disease control and use of the new inhaler device. Options may include: follow up by letter, review by the practice, PST or, where a patient obtains their supply from a community pharmacist, there is the opportunity to access the New Medicines Service to assess use of the device. 5. Agree how patients new to an Aerochamber will be counselled this can be done by practice nurses or community pharmacists. Please note that patient data must not be transferred to community pharmacists. Protocol title: Seretide to Fostair in COPD Page 4 of 12 NYAWC MMT

6. Agree content of patient letter possible forms of words are attached below. 7. Agree the number of repeats to issue for patients who are switched. 8. Any practice additions, deletions or amendments to the protocol. References EMC. (2014, 10). Fostair 100/6 inhilation solution. Retrieved 07 21, 2015, from Electronic Medicines Compendium: http://www.medicines.org.uk/emc/medicine/21006 Global Initiative for COPD. (2014). At a glance outpatient management reference for COPD, updated 2014. Retrieved 07 21, 2015, from Global Initiative for COPD: http://www.goldcopd.org/uploads/users/files/gold_ataglance_2014_jun11.pdf NICE. (2013, 06). Chronic obstructive pulmonary disease: Management of chronic obstructive pulmonary disease in adults in primary and secondary care. Retrieved 07 21, 2015, from NICE: http://www.nice.org.uk/guidance/cg101 NICE. (2014). Chronic obstructive pulmonary disease: beclometasone/formoterol (Fostair). NICE. (2014). COPD: Management of chronic obstructive pulmonary disease in adults in primary and secondary care (partial update). PrescQUIPP. (2013, 07). COPD - inhaled therapy in COPD. Retrieved 07 21, 2015, from PrescQUIPP: https://www.prescqipp.info/inhaled-therapy-in-copd/finish/191-inhaled-therapy-in-copd/691- bulletin-43-inhaled-therapy-in-copd Agreement to protocol Please detail any amendments to the protocol here/or attach a copy of agreed changes: Signature of practice prescribing lead/ manager Practice name Date Signed on behalf of NYAWC MMT Please note that the practice representative signing this protocol agrees to take responsibility for the notification of all relevant practice staff. Protocol title: Seretide to Fostair in COPD Page 5 of 12 NYAWC MMT

Possible letters patients without an Aerochamber Dear ~[Title/Initial/Surname] Change from Seretide 125mcg/250mcg* (*low dose delete as applicable) Evohaler to Fostair 100/6 The practice has been reviewing its prescribing of Seretide 125 Evohaler. This is to ensure that our patients receive the best treatment at the lowest cost to the NHS. As a result we have changed your future prescriptions to a different combination inhaler called Fostair 100/6 inhaler. This inhaler contains the same types of ingredients, a steroid (preventer) and a long acting airway opener (reliever) and works in the same way but is quicker acting. You should not notice any new side effects or worsening COPD symptoms with this new inhaler, but please do contact us if you do. Please note your inhaler will be kept in the fridge before dispensing but you should keep your inhaler at room temperature. You may notice a change in taste of the new inhaler this is because a different propellant is used to enable the inhaler to work more quickly to relieve your symptoms. Your medication will be changed automatically so please order your next prescription in the usual way. It would help the NHS save money if you would use up any remaining Seretide first. If you have any queries regarding this letter, please contact the surgery. Yours sincerely ~ [Usual GP/Registered GP/GP Prescribing Lead/Other] Dear ~[Title/Initial/Surname] Change from Seretide 250mcg Evohaler to Fostair 100/6 The practice has been reviewing its prescribing of Seretide 250 Evohaler. This is to ensure our patients receive the best treatment offering the best value for the NHS. It is important to treat your COPD with the lowest effective steroid dose. As a result we have changed your future prescriptions to a different combination inhaler called Fostair 100/6. This inhaler contains the same type of ingredients, a steroid (preventer) and a long acting airway opener (reliever) and works in the same way but is quicker acting. You should not notice any new side effects or worsening COPD symptoms with this new inhaler, but please do contact us if you do. Please note your inhaler will be kept in the fridge before dispensing but you should keep your inhaler at room temperature. You may notice a change in taste of the new inhaler this is because a different propellant is used to enable the inhaler to work more quickly to relieve your symptoms. Your medication will be changed automatically so please order your next prescription in the usual way. It would help the NHS save money if you would use up any remaining Seretide first. If you have any queries regarding this letter, please contact the surgery. Yours sincerely ~ [Usual GP/Registered GP/GP Prescribing Lead/Other] Protocol title: Seretide to Fostair in COPD Page 6 of 12 NYAWC MMT

Possible letters patients with Aerochamber Dear ~[Title/Initial/Surname] Change from Seretide 125mcg/250mcg* (*low dose delete as applicable) Evohaler to Fostair 100/6 The practice has been reviewing its prescribing of Seretide 125 Evohaler. This is to ensure that our patients receive the best treatment at the lowest cost to the NHS. As a result we have changed your future prescriptions to a different combination inhaler called Fostair 100/6 inhaler. This inhaler contains the same types of ingredients, a steroid (preventer) and a long acting airway opener (reliever) and works in the same way but is quicker acting. You should not notice any new side effects or worsening COPD symptoms with this new inhaler, but please do contact us if you do. Please note your inhaler will be kept in the fridge before dispensing but you should keep your inhaler at room temperature. You may notice a change in taste of the new inhaler this is because a different propellant is used to enable the inhaler to work more quickly to relieve your symptoms. Our records show that you have been using a Volumatic spacer device with your inhaler please note that this will not work with your new Fostair inhaler. As a result, we have changed your prescription to another spacer device called an Aerochamber. This will fit with your Fostair inhaler. You will need to be shown how to use this. Your community pharmacist or practice nurse will be able to help you with this. Your medication will be changed automatically so please order your next prescription in the usual way. It would help the NHS save money if you would use up any remaining Seretide first. If you have any queries regarding this letter, please contact the surgery. Yours sincerely ~ [Usual GP/Registered GP/GP Prescribing Lead/Other] Dear ~[Title/Initial/Surname] Change from Seretide 250mcg Evohaler to Fostair 100/6 The practice has been reviewing its prescribing of Seretide 250 Evohaler. This is to ensure our patients receive the best treatment offering the best value for the NHS. It is important to treat your COPD with the lowest effective steroid dose. As a result we have changed your future prescriptions to a different combination inhaler called Fostair 100/6. This inhaler contains the same type of ingredients, a steroid (preventer) and a long acting airway opener (reliever) and works in the same way but is quicker acting. You should not notice any new side effects or worsening COPD symptoms with this new inhaler, but please do contact us if you do. Please note your inhaler will be kept in the fridge before dispensing but you should keep your inhaler at room temperature. You may notice a change in taste of the new inhaler this is because a different propellant is used to enable the inhaler to work more quickly to relieve your symptoms. Our records show that you have been using a Volumatic spacer device with your inhaler please note that this will not work with your new Fostair inhaler. As a result, we have changed your prescription to another spacer device called an Aerochamber. This will fit with your Fostair inhaler. You will need to be shown how to use this. Your community pharmacist or practice nurse will be able to help you with this. Your medication will be changed automatically so please order your next prescription in the usual way. It would help the NHS save money if you would use up any remaining Seretide first. If you have any queries regarding this letter, please contact the surgery. Yours sincerely ~ [Usual GP/Registered GP/GP Prescribing Lead/Other] Protocol title: Seretide to Fostair in COPD Page 7 of 12 NYAWC MMT

Possible information for inclusion Example of patient information WHY IS MY INHALER BEING CHANGED? A recent review of inhalers used for a lung condition called COPD has also shown that Fostair is a more cost-effective inhaler choice for patients who need a combination inhaler. It has both a lower price and a lower concentration of drug. Due to more efficient delivery it results the same beneficial effect as previous inhaler types, with the potential for fewer side effects. This is in line with national NHS recommendations. WHAT IS THE DIFFERENCE BETWEEN THESE TWO INHALERS? Fostair contains beclomethasone (a preventer) and formoterol (long acting airway opener). Please read the medicine label or ask your health professional for advice. You may also be prescribed a spacer to help you use your MDI. HOW DO I USE MY NEW INHALER? You should read the information leaflet that comes with your inhaler, which has detailed instructions on how to use your inhaler. Please ask your pharmacist if you have any questions. WILL THE NEW INHALER CAUSE MORE SIDE EFFECTS? It is unlikely that you will get more side effects with your new inhaler as they contain the same type of medicines that your current inhaler contains. However, if you do find that your symptoms worsen or you experience side effects then you should inform your GP surgery. WILL I BE ASKED TO CHANGE MEDICINES AGAIN IN THE FUTURE? Medicines are constantly reviewed to ensure that they are the most optimal choice for the patient and the NHS as a whole. Therefore you may be affected by future changes. WHO CAN I ASK FOR MORE ADVICE? You may wish to contact your local community pharmacy when you present your first prescription and ask for a new medicines review. The New Medicine Service is a free NHS service, offered through your pharmacy (chemist), to help you understand your condition and get the most out of your new inhaler. Agreement to letters / inclusion Please detail any amendments to the letters here/or attach a copy of agreed changes: Signature of practice prescribing lead/ manager Practice name Date Signed on behalf of NYAWC MMT Protocol title: Seretide to Fostair in COPD Page 8 of 12 NYAWC MMT

Appendix 1: Data Collection Form: -Seretide evohaler to Fostair in COPD ID Age Inhaler/ strength and dose Indication Allergy Status Checked Y/N Compliance: no. of inhalers in last 12 months No. other inhalers in last 12 months Previously tried Fostair? Y/N If Y why stopped Using spacer device? Flag if not an Aerochamber plus device Date of last respiratory review Number of exacerbations in last 12 months FEV 1 < 50% History of a problem using an MDI? Y/N Flag to GP/Respirat ory specialist for review Suitable to switch? Switche d & letter sent Protocol title: Seretide to Fostair in COPD Page 9 of 12 NYAWC MMT and amendments, including updated hyperlinks. Please use the online version to ensure use of the latest version.

Appendix 2: Proposed letter to community pharmacies to be used IF RELEVANT see section to flag for special consideration point 9 Unit 1, Grimbald Crag Court St James Business Park Knaresborough North Yorkshire HG5 8QB Date To: North Yorkshire Community Pharmacies Re: Seretide 250mcg/125mcg Evohaler switch to Fostair 100/6 MDI in COPD. Dear Colleague, As part of the COPD workstream, the CCG medicines management team plan to carry out review of COPD patients presently prescribed Seretide Evohalers with a view to consider switching them to the licensed inhaler Fostair in line with local COPD guidelines. Table 1. Switch recommendation from Seretide Evohaler to Fostair 100/6 MDI in COPD patients Seretide to Fostair (beclometasone and formoterol) 100/6 MDI Current prescription Product and dose to switch to Seretide 125 Evohaler Seretide 250 Evohaler 1 puff TWICE daily Seretide 250 Evohaler (This switch will only be undertaken IF agreed by a prescriber on an individual patient basis) Fostair 100/6 Inhaler Fostair 100/6 Inhaler Fostair 100/6 Inhaler As this is a switch is to a different product, the team considers that it would be beneficial for these patients to receive a review from a community pharmacist as part of the new medicines service. Protocol title: Seretide to Fostair in COPD Page 10 of 12 NYAWC MMT

For general background information and if you are able to perform such a review, then you may find the following points useful: Fostair is the only MDI licensed for treatment of COPD. Fostair is licensed for use in adult patients with severe COPD (FEV1 <50% predicted normal) and a history of repeated exacerbation, who have significant symptoms despite regular therapy with long-acting bronchodilators. Prior to dispensing to the patient Fostair should be stored in a refrigerator (2-8 C); after dispensing- does not need to be stored in a refrigerator and has a shelf-life of 5-months at room temperature. Patients that previously used a Volumatic will be changed to an aerochamber plus and will require counselling as the Volumatic is not compatible with Fostair MDI. In some cases practice nurses will undertake this counselling; alternatively we may request that you undertake this as a part of a NMS. Seretide 250 Evohaler, 2 puffs BD ((2000mcg BDP* equivalent/day +100mcg salmeterol/day) when switched to Fostair 100/6 MDI, 2 puffs BD ((800mcg BDP* equivalent/day + 24mcg formoterol/day) is a step down in equivalent steroid dose. There may be a small increased risk of exacerbation in COPD which should be checked for at the follow up visit. We have agreed with Community Pharmacy North Yorkshire that we would bring this matter to your attention. We feel that community pharmacists are well placed to support medicines optimisation interventions in primary care such as this and we thank you in anticipation of your support. If you have any further question then do not hesitate to contact the CCG medicines management team on.. Yours sincerely Name title Protocol title: Seretide to Fostair in COPD Page 11 of 12 NYAWC MMT

Document version control Version State changes New version Actioned by V1.0 Minor adj. after road-test and change of logo and footer. V2.0 DC and CR V2.0 Change on page 7 from V2.01 DC and SK exacerbations in 3 months to 12 months V2.01 Changes to letters to reflect a possible step down in steroid dose in the higher strength Seretide V2.02 DC and CR Evohaler. Possible patient information leaflet edited and the addition of a discussion point for patients found to be on a higher dose of Seretide Evohaler. V2 02 Review and clarification of switch V2 03 RA and SK process. Use of on-line version statement; new discuss terminal patients with practice statement. Reference made to comm. Pharmacy correspondence. Addition of new initial statement regarding protocol use. V2 03 Review of all content and addition of letter for local pharmacies. V2 04 RA February 2017 Protocol title: Seretide to Fostair in COPD Page 12 of 12 NYAWC MMT